HealthyPhase 1NCT01845077

Relative Bioavailability of 2 Fixed Dose Combinations of Linagliptin/Metformin Compared With Single Tablets

A Phase 1 study testing 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC and 5 mg Linagliptin (Tradjenta) in people with Healthy, run by Boehringer Ingelheim at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of the trial is to demonstrate the relative bioavailability of 2 newly developed fixed dose combination (FDC) tablets containing linagliptin \& metformin and the single tablets of linagliptin and metformin when administered singularly. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC and 5 mg Linagliptin (Tradjenta)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: May 2013to Aug 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males or females
Age 18 -50 years (incl)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subjects must be able to understand and comply with study requirements

Who cannot join

Any deviation from healthy condition

Trial locations and contacts

1 site in 1 country.

United States1 site

1288.8.1 Boehringer Ingelheim Investigational Site
Austin, Texas

Other trials in United States

About this study

Official title: Relative Bioavailability of Two Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the Free Combination of Linagliptin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)

Conditions: Healthy
Being tested: 2x500 mg Metformin (Glumetza), 5 mg Linagliptin/1000 mg Metformin FDC, 5 mg Linagliptin (Tradjenta), 3x500 mg Metformin (Glumetza), 2 x 500 mg Metformin (Glumetza)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2x500 mg Metformin (Glumetza)Drug
2 tablets
5 mg Linagliptin/1000 mg Metformin FDCDrug
FDC tablet
5 mg Linagliptin (Tradjenta)Drug
1 tablet
5 mg Linagliptin (Tradjenta)Drug
1 tablet
3x500 mg Metformin (Glumetza)Drug
3 tablets
5 mg Linagliptin (Tradjenta)Drug
1 tablet
2 x 500 mg Metformin (Glumetza)Drug
2 tablets
5 mg Linagliptin/1000mg Metformin FDCDrug
FDC Tablet
2 x 2.5 mg Linagliptin/750 mg Metformin FDCDrug
2 FDC tablets

Study groups in NCT01845077
Study group	Role	What they receive
5 mg Linagliptin/1000 mg Metformin, fed	Active comparator	3 single tablets under fed conditions Receives: Drug: 2x500 mg Metformin (Glumetza); Drug: 5 mg Linagliptin (Tradjenta)
5 mg Linagliptin/1500 mg Metformin FDC	Experimental	2 FDC tablets under fasted conditions Receives: Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC
5 mg Linagliptin/1500 mg Metformin	Active comparator	4 single tablets under fasted conditions Receives: Drug: 3x500 mg Metformin (Glumetza); Drug: 5 mg Linagliptin (Tradjenta)
5 mg Linagliptin/1000 mg Metformin FDC	Experimental	1 fixed dose combination(FDC) tablet under fasted conditions Receives: Drug: 5 mg Linagliptin/1000mg Metformin FDC
5 mg Linagliptin/1000 mg Metformin	Active comparator	3 single tablets under fasted conditions Receives: Drug: 5 mg Linagliptin (Tradjenta); Drug: 2 x 500 mg Metformin (Glumetza)
5mg Linagliptin/1000mg Metformin, FDCfed	Experimental	1 FDC tablet under fed conditions Receives: Drug: 5 mg Linagliptin/1000 mg Metformin FDC

What is being measured

The primary outcome is the main question the study is designed to answer.

AUC0-72 of Linagliptin
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Cmax of Linagliptin
Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
AUC0-tz of Metformin
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Cmax of Metformin
Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

Secondary outcomes (2)

AUC0-infinity of Linagliptin
Area under the concentration-time curve of Linagliptin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
AUC0-infinity of Metformin
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 extrapolated to infinity based on predicted last concentration values. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Measured: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Aug 2013

First posted3 May 2013 (estimated)
Study startMay 2013
Primary completionAug 2013
Study completionAug 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01845077
Sponsor's protocol ID: 1288.8
Status last verified: Jul 2014
First submitted: 30 Apr 2013
Last updated: 19 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of Two Newly Developed Extended Release FDC Tablet Strengths (5mg/1000mg and 2.5 mg/750 mg) of Linagliptin/Metformin Extended Release Compared With the Free Combination of Linagliptin and Metformin Extended Release in Healthy Subjects (an Open-label, Randomised, Single Dose, Two-way Crossover Study)
ClinicalTrials.gov ID: NCT01845077
Acronym / sponsor ID: 1288.8
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: May 2013
Primary completion: Aug 2013 (actual)
Study completion: Aug 2013 (actual)
First posted: 3 May 2013 (estimated)
Results: Posted 19 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
5 mg Linagliptin/1000 mg Metformin, fed	Active comparator	Drug: 2x500 mg Metformin (Glumetza), Drug: 5 mg Linagliptin (Tradjenta)3 single tablets under fed conditions
5 mg Linagliptin/1500 mg Metformin FDC	Experimental	Drug: 2 x 2.5 mg Linagliptin/750 mg Metformin FDC2 FDC tablets under fasted conditions
5 mg Linagliptin/1500 mg Metformin	Active comparator	Drug: 3x500 mg Metformin (Glumetza), Drug: 5 mg Linagliptin (Tradjenta)4 single tablets under fasted conditions
5 mg Linagliptin/1000 mg Metformin FDC	Experimental	Drug: 5 mg Linagliptin/1000mg Metformin FDC1 fixed dose combination(FDC) tablet under fasted conditions
5 mg Linagliptin/1000 mg Metformin	Active comparator	Drug: 5 mg Linagliptin (Tradjenta), Drug: 2 x 500 mg Metformin (Glumetza)3 single tablets under fasted conditions
5mg Linagliptin/1000mg Metformin, FDCfed	Experimental	Drug: 5 mg Linagliptin/1000 mg Metformin FDC1 FDC tablet under fed conditions

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males or females
Age 18 -50 years (incl)
Body Mass Index (BMI) 18.5 to 29.9 kg/m2 (incl.)
Subjects must be able to understand and comply with study requirements

Key exclusion criteria (1 listed)

Any deviation from healthy condition

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
2x500 mg Metformin (Glumetza)2 tablets	Drug	5 mg Linagliptin/1000 mg Metformin, fed
5 mg Linagliptin/1000 mg Metformin FDCFDC tablet	Drug	5mg Linagliptin/1000mg Metformin, FDCfed
5 mg Linagliptin (Tradjenta)1 tablet	Drug	5 mg Linagliptin/1000 mg Metformin, fed
5 mg Linagliptin (Tradjenta)1 tablet	Drug	5 mg Linagliptin/1000 mg Metformin
3x500 mg Metformin (Glumetza)3 tablets	Drug	5 mg Linagliptin/1500 mg Metformin
5 mg Linagliptin (Tradjenta)1 tablet	Drug	5 mg Linagliptin/1500 mg Metformin
2 x 500 mg Metformin (Glumetza)2 tablets	Drug	5 mg Linagliptin/1000 mg Metformin
5 mg Linagliptin/1000mg Metformin FDCFDC Tablet	Drug	5 mg Linagliptin/1000 mg Metformin FDC
2 x 2.5 mg Linagliptin/750 mg Metformin FDC2 FDC tablets	Drug	5 mg Linagliptin/1500 mg Metformin FDC

Primary outcome

AUC0-72 of Linagliptin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Area Under the Concentration-time Curve of Linagliptin in Plasma Over the Time Interval 0 to 72 Hours (AUC0-72). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Cmax of Linagliptin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Maximum Measured Concentration (Cmax) of Linagliptin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
AUC0-tz of Metformin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Area under the concentration-time curve of Metformin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.
Cmax of Metformin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
Maximum Measured Concentration (Cmax) of Metformin in plasma. The shown geometric coefficients of variation (gCV) are the pooled intra-individual gCV - each over 2 treatment groups (FDC1000 fasted and L+M1000 fasted, FDC1000 fed and L+M1000 fed, FDC1500 fasted and L+M1500 fasted). The geometric means are actually adjusted geometric means.

2 secondary outcomes

AUC0-infinity of Linagliptin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period
AUC0-infinity of Metformin
Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period

Results and safety

Results posted to the registry on 19 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FDC1000 Fasted, Then L+M1000 Fasted	12	12
L+M1000 Fasted, Then FDC1000 Fasted	12	12
FDC1000 Fed, Then L+M1000 Fed	12	12
L+M1000 Fed, Then FDC1000 Fed	12	12
FDC1500 Fasted, Then L+M1500 Fasted	12	12
L+M1500 Fasted, Then FDC1500 Fasted	12	12

Primary outcome: AUC0-72 of Linagliptin

Time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: nmol*h/L

Measure	FDC1000 Fasted n = 23	L+M1000 Fasted n = 23	FDC1000 Fed n = 21	L+M1000 Fed n = 21	FDC1500 Fasted n = 21	L+M1500 Fasted n = 22
Value	317.0 (8.0)	319.2 (8.0)	309.6 (5.5)	304.9 (5.5)	325.8 (5.1)	322.9 (5.1)

FDC1000 Fasted vs L+M1000 Fasted: Ratio of geometric means: 99.3 (90% CI 95.3 to 103.5), ANOVA
FDC1000 Fed vs L+M1000 Fed: Ratio of geometric means: 101.5 (90% CI 98.4 to 104.7), ANOVA
FDC1500 Fasted vs L+M1500 Fasted: Ratio of geometric means: 100.9 (90% CI 98.2 to 103.7), ANOVA

Population analysed: Pharmacokinetic set including all subjects of the TS who provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of pharmacokinetic endpoints.

Primary outcome: Cmax of Linagliptin

Measure	FDC1000 Fasted n = 23	L+M1000 Fasted n = 23	FDC1000 Fed n = 22	L+M1000 Fed n = 22	FDC1500 Fasted n = 21	L+M1500 Fasted n = 22
Value	10.1 (17.1)	10.6 (17.1)	7.7 (13.0)	7.9 (13.0)	11.6 (16.5)	10.7 (16.5)

FDC1000 Fasted vs L+M1000 Fasted: Ratio of geometric means: 94.9 (90% CI 86.8 to 103.6), ANOVA
FDC1000 Fed vs L+M1000 Fed: Ratio of geometric means: 96.8 (90% CI 90.2 to 103.8), ANOVA
FDC1500 Fasted vs L+M1500 Fasted: Ratio of geometric means: 108.6 (90% CI 99.5 to 118.5), ANOVA

Primary outcome: AUC0-tz of Metformin

Measure	FDC1000 Fasted n = 23	L+M1000 Fasted n = 23	FDC1000 Fed n = 22	L+M1000 Fed n = 23	FDC1500 Fasted n = 21	L+M1500 Fasted n = 22
Value	8629.0 (21.8)	8913.7 (21.8)	13772.0 (7.4)	13851.1 (7.4)	10472.9 (18.5)	10543.5 (18.5)

FDC1000 Fasted vs L+M1000 Fasted: Ratio of geometric means: 96.8 (90% CI 86.6 to 108.2), ANOVA
FDC1000 Fed vs L+M1000 Fed: Ratio of geometric means: 99.4 (90% CI 95.6 to 103.4), ANOVA
FDC1500 Fasted vs L+M1500 Fasted: Ratio of geometric means: 99.3 (90% CI 90.1 to 109.5), ANOVA

Primary outcome: Cmax of Metformin

Measure	FDC1000 Fasted n = 23	L+M1000 Fasted n = 23	FDC1000 Fed n = 22	L+M1000 Fed n = 23	FDC1500 Fasted n = 21	L+M1500 Fasted n = 22
Value	1047.4 (25.5)	1085.6 (25.5)	1119.0 (8.1)	1084.5 (8.1)	1347.0 (29.3)	1250.6 (29.3)

FDC1000 Fasted vs L+M1000 Fasted: Ratio of geometric means: 96.5 (90% CI 84.8 to 109.8), ANOVA
FDC1000 Fed vs L+M1000 Fed: Ratio of geometric means: 103.2 (90% CI 98.9 to 107.7), ANOVA
FDC1500 Fasted vs L+M1500 Fasted: Ratio of geometric means: 107.7 (90% CI 92.5 to 125.4), ANOVA

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FDC1000 Fasted	0 of 23 (0%)	1 of 23 (4.3%)	Not reported
L+M1000 Fasted	0 of 23 (0%)	1 of 23 (4.3%)	Not reported
FDC1000 Fed	0 of 22 (0%)	1 of 22 (4.5%)	Not reported
L+M1000 Fed	1 of 23 (4.3%)	0 of 23 (0%)	Not reported
FDC1500 Fasted	0 of 23 (0%)	3 of 23 (13%)	Not reported
L+M1500 Fasted	0 of 23 (0%)	2 of 23 (8.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-72 of Linagliptin (time frame: 1 hour (h) before drug administration and 20 minutes (min), 40 min, 1h, 1:30h, 2h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration at Day 1 of each treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01845077.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.